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FDA Warns Drug Maker Over Sterility Violations

Sept. 10, 2019, 6:02 PM

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Sharp Drugs Inc., dba Island Drug and Surgical

  • Issuing Office: Food and Drug Administration, Division of Pharmaceutical Quality Operations
  • Recipient: Joseph Pierro (owner)
  • Date: Aug. 2 (posted Sept. 10)
  • Inspection of facility in West Hampton Beach, N.Y., July 10-13, 2018

Alleged Infractions

  • Drug products intended to be sterile were prepared, packed, or held under insanitary conditions.
  • Company failed to perform adequate smoke studies to demonstrate unidirectional airflow within sensitive areas.
  • Company failed to perform media fills as required.
  • Company informed ...